Stratified Medicine Business Platform

Janssen UCL Medicinal Personalization
“JUMP”
TSB-SM
1101 CRD MED DBM 60171/101020
Stratified medicine opens up opportunities to significantly improve treatment outcomes in patient care while at the same time providing important new avenues to reduce costs. Stratified medicine does not only promise to upend existing structures governing clinical practice, it also challenges established business practices of firms in healthcare. This TSB funded project will develop and disseminate among key stakeholders a platform comprising three demand- and supply- side business tools to deal with commercial challenges tied to bringing new stratified medicine technologies to the market. The platform will support managers at firms as well as NHS-Trusts in moving new products and services into the clinic and strengthen UK competitiveness in stratified medicine.
The implementation of successful stratified medicine strategies relies on an inter-disciplinary, collaborative relationship between the NHS, Clinical and Academic, NHS commissioning, Health Technology Appraisal (NICE) and Industry. This TSB grant offers an opportunity for Janssen, UCL and UCL Partners to collaborate on evaluating a new, innovative and disruptive technology, which may have not occurred in such a manner without this grant. This is particularly relevant as Janssen will be bringing new directly acting antivirals (DAAs) to market for treatment of chronic Hepatitis C (CHC). As such, it is well aware that the NHS will need to adapt to managing CHC in a new, more intensive way. This TSB supported project is both apposite timing, as well as important to assist the NHS in recognizing this unmet need in stratified medicine. A successful outcome of this collaboration should assist Janssen via the implementation of the jointly developed business model to launch its DAAs using an integrated approach that should insure the best use of this drug class by providing the right medicine at the right dose for the right patient.
It is widely recognized that outcomes of biomarker and genetic prognostic research are not translated rapidly into clinical care pathways (see Portilla et al., 2010; Evans et al., 2010). One bottleneck is the ability of health services to assimilate into clinical care a coordinated therapeutic-diagnostic bundle, which requires the combination of an appropriate evidence base, a widely available diagnostic technology platform, and cost effectiveness data. The commercialization and implementation of such bundles require novel business models and relationship development tools that capture the interdependencies of the delivery of drugs and companion diagnostics in the clinic. The consortium has an excellent track record in developing such models and tools, which will in themselves, be individually unique. Moreover, through a modelling approach, based on a major disease area, our project aims to provide a template for overcoming this bottleneck within the NHS and elsewhere.
Currently, HCV viral load is performed in virology laboratories with an average turnaround time of 10-21 days (some expert clinics have a turnaround time of 1-2 days). While the technologies used to determine viral load are widely automated, the execution of these tests still requires the expertise of specialized lab techs and need to be run within a complex molecular diagnostic environment. The platform used to determine viral load in this project uses cutting edge technology that fully integrates sample preparation of nucleic acids, amplification and detection without user intervention. Patient blood is basically introduced into a proprietary cartridge that is introduced into a small bench top closed instrument that will deliver a viral load result to the patient during his/her stay in the clinic. The sheer availability of such key results during consultation can totally change the dynamics of current CHC treatment. This paradigm change may become beneficial for patients, NHS and commercial partners as it allows a more targeted and efficient use of new treatment options. The tools developed will be a combination of software products, expert consultancy services and educational programs that will provide commercial and operational benefits to the partners and beyond.
Through the consortium's close contacts to five London NHS Trusts (UCL & UCL Partners) and NHS providers across the UK, it will be able to facilitate the uptake of the CHC diagnostic platform into the NHS, allowing clinicians to perform screening of individuals at high risk of infection in settings that are currently difficult to access and where the separation between the clinical setting and laboratory leads to failure in diagnosing and retaining patients who would benefit from treatment. Results from this study will support a UK pilot implementation of a new point-of-need, clinic-based molecular diagnostic platform with initially HCV "viral load", but potentially other relevant clinical indices. Utilizing the considerable reach of Janssen will allow business models to be compared in other target markets versus this proposed, benchmark UK study.